HRP20220670T1 - Topikalne farmaceutske kompozicije - Google Patents
Topikalne farmaceutske kompozicije Download PDFInfo
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- HRP20220670T1 HRP20220670T1 HRP20220670TT HRP20220670T HRP20220670T1 HR P20220670 T1 HRP20220670 T1 HR P20220670T1 HR P20220670T T HRP20220670T T HR P20220670TT HR P20220670 T HRP20220670 T HR P20220670T HR P20220670 T1 HRP20220670 T1 HR P20220670T1
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- 239000012049 topical pharmaceutical composition Substances 0.000 title 1
- 239000000203 mixture Substances 0.000 claims 55
- 239000008251 pharmaceutical emulsion Substances 0.000 claims 15
- 230000000699 topical effect Effects 0.000 claims 15
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims 12
- 239000012071 phase Substances 0.000 claims 12
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims 10
- 239000003921 oil Substances 0.000 claims 10
- WPYMKLBDIGXBTP-UHFFFAOYSA-N benzoic acid Chemical compound OC(=O)C1=CC=CC=C1 WPYMKLBDIGXBTP-UHFFFAOYSA-N 0.000 claims 8
- 150000003839 salts Chemical class 0.000 claims 8
- 239000003963 antioxidant agent Substances 0.000 claims 7
- 230000003078 antioxidant effect Effects 0.000 claims 7
- ZISJNXNHJRQYJO-CMDGGOBGSA-N 5-[(e)-2-phenylethenyl]-2-propan-2-ylbenzene-1,3-diol Chemical compound C1=C(O)C(C(C)C)=C(O)C=C1\C=C\C1=CC=CC=C1 ZISJNXNHJRQYJO-CMDGGOBGSA-N 0.000 claims 6
- 239000002738 chelating agent Substances 0.000 claims 6
- 239000006184 cosolvent Substances 0.000 claims 6
- 239000003002 pH adjusting agent Substances 0.000 claims 6
- 239000003755 preservative agent Substances 0.000 claims 6
- 230000002335 preservative effect Effects 0.000 claims 6
- 239000004094 surface-active agent Substances 0.000 claims 6
- 239000005711 Benzoic acid Substances 0.000 claims 4
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 claims 4
- 235000010233 benzoic acid Nutrition 0.000 claims 4
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 4
- 208000035475 disorder Diseases 0.000 claims 4
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims 3
- 239000004322 Butylated hydroxytoluene Substances 0.000 claims 3
- NLZUEZXRPGMBCV-UHFFFAOYSA-N Butylhydroxytoluene Chemical compound CC1=CC(C(C)(C)C)=C(O)C(C(C)(C)C)=C1 NLZUEZXRPGMBCV-UHFFFAOYSA-N 0.000 claims 3
- 201000004624 Dermatitis Diseases 0.000 claims 3
- 235000010354 butylated hydroxytoluene Nutrition 0.000 claims 3
- 229940095259 butylated hydroxytoluene Drugs 0.000 claims 3
- XXJWXESWEXIICW-UHFFFAOYSA-N diethylene glycol monoethyl ether Chemical compound CCOCCOCCO XXJWXESWEXIICW-UHFFFAOYSA-N 0.000 claims 3
- 229940075557 diethylene glycol monoethyl ether Drugs 0.000 claims 3
- 229940057917 medium chain triglycerides Drugs 0.000 claims 3
- QFOHBWFCKVYLES-UHFFFAOYSA-N Butylparaben Chemical compound CCCCOC(=O)C1=CC=C(O)C=C1 QFOHBWFCKVYLES-UHFFFAOYSA-N 0.000 claims 2
- 241000701044 Human gammaherpesvirus 4 Species 0.000 claims 2
- 241000701806 Human papillomavirus Species 0.000 claims 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims 2
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- ZTHYODDOHIVTJV-UHFFFAOYSA-N Propyl gallate Chemical compound CCCOC(=O)C1=CC(O)=C(O)C(O)=C1 ZTHYODDOHIVTJV-UHFFFAOYSA-N 0.000 claims 2
- QAOWNCQODCNURD-UHFFFAOYSA-N Sulfuric acid Chemical compound OS(O)(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-N 0.000 claims 2
- 239000000872 buffer Substances 0.000 claims 2
- 239000007979 citrate buffer Substances 0.000 claims 2
- 229960001484 edetic acid Drugs 0.000 claims 2
- BEFDCLMNVWHSGT-UHFFFAOYSA-N ethenylcyclopentane Chemical compound C=CC1CCCC1 BEFDCLMNVWHSGT-UHFFFAOYSA-N 0.000 claims 2
- 239000003349 gelling agent Substances 0.000 claims 2
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 claims 2
- LXCFILQKKLGQFO-UHFFFAOYSA-N methylparaben Chemical compound COC(=O)C1=CC=C(O)C=C1 LXCFILQKKLGQFO-UHFFFAOYSA-N 0.000 claims 2
- 239000002480 mineral oil Substances 0.000 claims 2
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- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 2
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 2
- 229920000053 polysorbate 80 Polymers 0.000 claims 2
- 229940068968 polysorbate 80 Drugs 0.000 claims 2
- QELSKZZBTMNZEB-UHFFFAOYSA-N propylparaben Chemical compound CCCOC(=O)C1=CC=C(O)C=C1 QELSKZZBTMNZEB-UHFFFAOYSA-N 0.000 claims 2
- 239000008213 purified water Substances 0.000 claims 2
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- 235000010199 sorbic acid Nutrition 0.000 claims 2
- 229940075582 sorbic acid Drugs 0.000 claims 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 2
- JNYAEWCLZODPBN-JGWLITMVSA-N (2r,3r,4s)-2-[(1r)-1,2-dihydroxyethyl]oxolane-3,4-diol Chemical class OC[C@@H](O)[C@H]1OC[C@H](O)[C@H]1O JNYAEWCLZODPBN-JGWLITMVSA-N 0.000 claims 1
- DBHODFSFBXJZNY-UHFFFAOYSA-N 2,4-dichlorobenzyl alcohol Chemical compound OCC1=CC=C(Cl)C=C1Cl DBHODFSFBXJZNY-UHFFFAOYSA-N 0.000 claims 1
- QCDWFXQBSFUVSP-UHFFFAOYSA-N 2-phenoxyethanol Chemical compound OCCOC1=CC=CC=C1 QCDWFXQBSFUVSP-UHFFFAOYSA-N 0.000 claims 1
- OSDLLIBGSJNGJE-UHFFFAOYSA-N 4-chloro-3,5-dimethylphenol Chemical compound CC1=CC(O)=CC(C)=C1Cl OSDLLIBGSJNGJE-UHFFFAOYSA-N 0.000 claims 1
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- AEMOLEFTQBMNLQ-AQKNRBDQSA-N D-glucopyranuronic acid Chemical compound OC1O[C@H](C(O)=O)[C@@H](O)[C@H](O)[C@H]1O AEMOLEFTQBMNLQ-AQKNRBDQSA-N 0.000 claims 1
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- FEWJPZIEWOKRBE-JCYAYHJZSA-N Dextrotartaric acid Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O FEWJPZIEWOKRBE-JCYAYHJZSA-N 0.000 claims 1
- 206010015150 Erythema Diseases 0.000 claims 1
- IAJILQKETJEXLJ-UHFFFAOYSA-N Galacturonsaeure Natural products O=CC(O)C(O)C(O)C(O)C(O)=O IAJILQKETJEXLJ-UHFFFAOYSA-N 0.000 claims 1
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- 208000009889 Herpes Simplex Diseases 0.000 claims 1
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- 208000007766 Kaposi sarcoma Diseases 0.000 claims 1
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- 206010064281 Malignant atrophic papulosis Diseases 0.000 claims 1
- 208000002030 Merkel cell carcinoma Diseases 0.000 claims 1
- GRYLNZFGIOXLOG-UHFFFAOYSA-N Nitric acid Chemical compound O[N+]([O-])=O GRYLNZFGIOXLOG-UHFFFAOYSA-N 0.000 claims 1
- 208000010195 Onychomycosis Diseases 0.000 claims 1
- 206010034277 Pemphigoid Diseases 0.000 claims 1
- 241000721454 Pemphigus Species 0.000 claims 1
- 208000009675 Perioral Dermatitis Diseases 0.000 claims 1
- ABLZXFCXXLZCGV-UHFFFAOYSA-N Phosphorous acid Chemical class OP(O)=O ABLZXFCXXLZCGV-UHFFFAOYSA-N 0.000 claims 1
- 208000009077 Pigmented Nevus Diseases 0.000 claims 1
- OFOBLEOULBTSOW-UHFFFAOYSA-N Propanedioic acid Natural products OC(=O)CC(O)=O OFOBLEOULBTSOW-UHFFFAOYSA-N 0.000 claims 1
- 201000004681 Psoriasis Diseases 0.000 claims 1
- 201000001263 Psoriatic Arthritis Diseases 0.000 claims 1
- 208000036824 Psoriatic arthropathy Diseases 0.000 claims 1
- 241001303601 Rosacea Species 0.000 claims 1
- 206010039792 Seborrhoea Diseases 0.000 claims 1
- 206010040865 Skin hyperpigmentation Diseases 0.000 claims 1
- 206010040868 Skin hypopigmentation Diseases 0.000 claims 1
- KDYFGRWQOYBRFD-UHFFFAOYSA-N Succinic acid Natural products OC(=O)CCC(O)=O KDYFGRWQOYBRFD-UHFFFAOYSA-N 0.000 claims 1
- FEWJPZIEWOKRBE-UHFFFAOYSA-N Tartaric acid Natural products [H+].[H+].[O-]C(=O)C(O)C(O)C([O-])=O FEWJPZIEWOKRBE-UHFFFAOYSA-N 0.000 claims 1
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- 241000130764 Tinea Species 0.000 claims 1
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- 208000027418 Wounds and injury Diseases 0.000 claims 1
- 240000008042 Zea mays Species 0.000 claims 1
- 235000005824 Zea mays ssp. parviglumis Nutrition 0.000 claims 1
- 235000002017 Zea mays subsp mays Nutrition 0.000 claims 1
- 239000002253 acid Substances 0.000 claims 1
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- 208000002029 allergic contact dermatitis Diseases 0.000 claims 1
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- KDYFGRWQOYBRFD-NUQCWPJISA-N butanedioic acid Chemical compound O[14C](=O)CC[14C](O)=O KDYFGRWQOYBRFD-NUQCWPJISA-N 0.000 claims 1
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- 235000015165 citric acid Nutrition 0.000 claims 1
- 235000005822 corn Nutrition 0.000 claims 1
- 208000017763 cutaneous neuroendocrine carcinoma Diseases 0.000 claims 1
- GVJHHUAWPYXKBD-UHFFFAOYSA-N d-alpha-tocopherol Natural products OC1=C(C)C(C)=C2OC(CCCC(C)CCCC(C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-UHFFFAOYSA-N 0.000 claims 1
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- SOROIESOUPGGFO-UHFFFAOYSA-N diazolidinylurea Chemical compound OCNC(=O)N(CO)C1N(CO)C(=O)N(CO)C1=O SOROIESOUPGGFO-UHFFFAOYSA-N 0.000 claims 1
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- 150000002148 esters Chemical class 0.000 claims 1
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- 229960001617 ethyl hydroxybenzoate Drugs 0.000 claims 1
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- ZCTXEAQXZGPWFG-UHFFFAOYSA-N imidurea Chemical compound O=C1NC(=O)N(CO)C1NC(=O)NCNC(=O)NC1C(=O)NC(=O)N1CO ZCTXEAQXZGPWFG-UHFFFAOYSA-N 0.000 claims 1
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- GCLGEJMYGQKIIW-UHFFFAOYSA-H sodium hexametaphosphate Chemical compound [Na]OP1(=O)OP(=O)(O[Na])OP(=O)(O[Na])OP(=O)(O[Na])OP(=O)(O[Na])OP(=O)(O[Na])O1 GCLGEJMYGQKIIW-UHFFFAOYSA-H 0.000 claims 1
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Classifications
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
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Claims (18)
1. Topikalna farmaceutska kompozicija emulzije koja sadrži:
3,5-dihidroksi-4-izopropil-trans-stilben ili njegovu farmaceutski prihvatljivu sol,
uljanu fazu u količini od oko 5% do oko 35% po težini, na bazi ukupne težine kompozicije,
vodenu fazu,
surfaktant u količini od oko 1% do oko 20% po težini, na osnovu ukupne težine kompozicije, i
antioksidans;
pri čemu je kompozicija emulzije homogena,
i pri čemu je uljana faza u suštini bez vazelina.
2. Topikalna farmaceutska kompozicija emulzije prema zahtjevu 1, naznačena time što kompozicija izborno sadrži jedan ili više dodatnih dermatološki prihvatljivih ekscipijenasa izabranih od sredstva za podešavanje pH, kelatnog sredstva, konzervansa, ko-otapala, pojačivača prodiranja, humektanta, sredstva za zgušnjavanje ili želirajućeg sredstva ili sredstva za izgradnju viskoziteta, mirisa, boje i njihovih mješavina.
3. Topikalna farmaceutska kompozicija emulzije prema zahtjevu 2, naznačena time što je sredstvo za podešavanje pH izabrano iz grupe koja se sastoji od mliječne kiseline, octene kiseline, maleinske kiseline, jantarne kiseline, limunske kiseline, benzojeve kiseline, borne kiseline, sorbinske kiseline, vinske kiseline, edetske kiseline, fosforne kiseline, dušične kiseline, sumporne kiseline i klorovodične kiseline i njihovih mješavina.
4. Topikalna farmaceutska kompozicija emulzije prema zahtjevu 2 ili 3, naznačena time što je kelatno sredstvo izabrano iz grupe koja se sastoji od limunske kiseline, glukuronske kiseline, natrij heksametafosfata, cink heksametafosfata, etilen diamin tetraoctene kiseline, fosfonata, njihovih soli i njihovih mješavina.
5. Topikalna farmaceutska kompozicija emulzije prema zahtjevima 2 do 4, naznačena time što je konzervans izabran iz grupe koja se sastoji od benzil alkohola, imidazolidinil uree, diazolidinil uree, dihlorobenzil alkohola, kloroksilenola, metil parabena, etil parabena, propil parabena, butil parabena, fenoksi etanola, sorbinske kiseline, benzojeve kiseline, njihovih soli i njihovih mješavina.
6. Topikalna farmaceutska kompozicija emulzije prema zahtjevima 2 do 5, naznačena time što je ko-otapalo mješavina propilen glikola i dietilen glikol monoetil etera.
7. Topikalna farmaceutska kompozicija emulzije prema bilo kojem od prethodnih zahtjeva, naznačena time što je 3,5-dihidroksi-4-izopropil-trans-stilben ili njegova farmaceutski prihvatljiva sol u količini od oko 0.05% do oko 2% po težini, na bazi ukupne težine kompozicije.
8. Topikalna farmaceutska kompozicija emulzije prema zahtjevu 1, naznačena time što uljana faza sadrži trigliceride srednjeg lanca.
9. Topikalna farmaceutska kompozicija emulzije prema bilo kojem od prethodnih zahtjeva, naznačena time što surfaktant sadrži jedan ili više ne-ionskih surfaktanata.
10. Topikalna farmaceutska kompozicija emulzije prema zahtjevu 9, naznačena time što je jedan ili više ne-ionskih surfaktanata izabrano od etoksiliranih etera masnog alkohola, PEG ricinusovih ulja, PEG estera, propilen glikol estera, gliceril estera i derivata, polimernih etera, derivata sorbitana, masnih alkohola, emulgirajućih voskova i njihovih mješavina.
11. Topikalna farmaceutska kompozicija emulzije prema bilo kojem od prethodnih zahtjeva, naznačena time što je antioksidant u količini od oko 0.001% do oko 5% po težini, oko 0.01% do 1% po težini, oko 0.05% po težini ili oko 0.1% po težini, na bazi ukupne težine kompozicije.
12. Topikalna farmaceutska kompozicija emulzije prema bilo kojem od prethodnih zahtjeva, naznačena time što je antioksidant izabran iz grupe koja se sastoji od propil galata, butiliranog hidroksitoluena, tokoferola i njihovih mješavina.
13. Topikalna farmaceutska kompozicija emulzije prema bilo kojem od prethodnih zahtjeva, naznačena time što je prosječna veličina kapljica uljane faze oko 0.05 mikrona do oko 35 mikrona, oko 0.05 mikrona do oko 5 mikrona, oko 0.05 do oko 1 mikrona, ili oko 0,1 mikrona do oko 0.75 mikrona.
14. Topikalna farmaceutska kompozicija emulzije prema zahtjevu 1, naznačena time što kompozicija sadrži:
3,5-dihidroksi-4-izopropil-trans-stilben ili njegovu farmaceutski prihvatljivu sol u količini od oko 0.5% po težini, na bazi ukupne težine kompozicije;
uljanu fazu koja sadrži trigliceride srednjeg lanca u količini od oko 10% po težini, na bazi ukupne težine kompozicije;
pročišćenu vodenu fazu u količini od oko 65.18% po težini, na bazi ukupne težine kompozicije;
surfaktant, pri čemu je surfaktant mješavina od oko 7.20% najmanje jednog ne-ionskog emulgirajućeg voska NF po težini, oko 1.80% po težini steareta-2, oko 1.10% po težini steareta-20 i 1.5% polisorbata 80 po težini, na bazi ukupne težine kompozicije;
antioksidans u količini od oko 0.10%, na bazi ukupne težine kompozicije, pri čemu je antioksidans butilirani hidroksitoluen;
sredstvo za podešavanje pH u količini od oko 0.27% po težini, na osnovu ukupne težine kompozicije, pri čemu sredstvo za podešavanje pH je citratni pufer/pufer limunske kiseline;
kelatno sredstvo u količini od oko 0.10% po težini, na bazi ukupne težine kompozicije, pri čemu je kelatno sredstvo dinatrij etilen diamin tetraoctena kiselina;
konzervans u količini od oko 0.25% po težini, na osnovu ukupne težine kompozicije, pri čemu je konzervans benzojeva kiselina; i
ko-otapalo, gdje je ko-otapalo mješavina od oko 10% po težini propilen glikola i oko 2% dietilen glikol monoetil etera, na bazi ukupne težine kompozicije;
pri čemu je 3,5-dihidroksi-4-izopropil-trans-stilben ili njegova farmaceutski prihvatljiva sol otopljen u uljanoj fazi;
pri čemu je uljana faza u suštini bez mineralnog ulja.
15. Topikalna farmaceutska kompozicija emulzije prema zahtjevu 1, naznačena time što kompozicija sadrži:
3,5-dihidroksi-4-izopropil-trans-stilben ili njegovu farmaceutski prihvatljivu sol u količini od oko 1.0% po težini, na bazi ukupne težine kompozicije;
uljanu fazu koja sadrži trigliceride srednjeg lanca u količini od oko 10% po težini, na bazi ukupne težine kompozicije;
pročišćenu vodenu fazu u količini od oko 64.68% po težini, na bazi ukupne težine kompozicije;
surfaktant, pri čemu je surfaktant mješavina od oko 7.20% najmanje jednog ne-ionskog emulgirajućeg voska NF po težini, oko 1.80% po težini steareta-2, oko 1.10% po težini steareta-20 i 1.5% polisorbata 80 po težini, na bazi ukupne težine kompozicije;
antioksidans u količini od oko 0.10%, na bazi ukupne težine kompozicije, pri čemu je antioksidans butilirani hidroksitoluen;
sredstvo za podešavanje pH u količini od oko 0.27% po težini, na bazi ukupne težine kompozicije, pri čemu sredstvo za podešavanje pH je citratni pufer/pufer limunske kiseline;
kelatno sredstvo u količini od oko 0.10% po težini, na bazi ukupne težine kompozicije, pri čemu je kelatno sredstvo dinatrij etilen diamin tetraoctena kiselina;
konzervans u količini od oko 0.25% po težini, na bazi ukupne težine kompozicije, pri čemu je konzervans benzojeva kiselina; i
ko-otapalo, gdje je ko-otapalo mješavina od oko 10% po težini propilen glikola i oko 2% dietilen glikol monoetil etera, na bazi ukupne težine kompozicije;
pri čemu je 3,5-dihidroksi-4-izopropil-trans-stilben ili njegova farmaceutski prihvatljiva sol otopljen u uljanoj fazi;
pri čemu je uljana faza u suštini bez mineralnog ulja.
16. Kompozicija prema bilo kojem od prethodnih zahtjeva za uporabu u liječenju dermatološkog stanja ili poremećaja.
17. Kompozicija za uporabu prema zahtjevu 16, naznačena time što je dermatološko stanje ili poremećaj izabran iz grupe koja se sastoji od sljedećih: psorijaza, psorijatični artritis, eksfolijativni dermatitis, pityriasis rosea, lichen planus, lichen nitidus, porokeratoza, pemfigus, bulozni pemfigoid, epidermamolysis bullosa acquisita, pustularne erupcije na dlanovima ili tabanima, poremećaji kose, noktiju, rozacea, perioralni dermatitis ili folikularni sindromi, rak pločastih stanica, rak bazalnih stanica, keratoakantom, benigni tumori epitela, rak merkelovih stanica, pigmentni poremećaji, albinizam, hipomelanoze, hipermelanoze, melanocitni nevusi, melanom, eritema elavatum diutinum, eozinofili, granulom facilae, pioderma gangrenozum, maligna atrofična papuloza, fibrozne lezije dermisa i mekog tkiva, Kaposi sarkom, paninkulitis, lipodistrofija, engioedem, bolest presađivanja protiv domaćina, alergijski kontaktni dermatitis, autosenzibilizirajući dermatitis, atopijski dermatitis, seboreični dermatitis, termička povreda, radijacijski dermatitis, kurje oči, žuljevi, akutno i kronično UV zračenje, fotosenzibilizacija, lepra, lajmska borelioza, onihomikoza, tinea pedra, rubeola, male boginje, herpes simpleks, EBV (Epstein-Barr virus), HPV (humani papiloma virus) i bradavice.
18. Kompozicija prema bilo kojem od zahtjeva 1-16 za uporabu u terapiji.
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US11497718B2 (en) | 2018-11-13 | 2022-11-15 | Dermavant Sciences GmbH | Use of tapinarof for the treatment of atopic dermatitis |
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US20200383887A1 (en) * | 2019-06-04 | 2020-12-10 | L'oreal | Oxygenate skin treatment system |
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